hydromorphone hydrochloride

Generic: hydromorphone hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydromorphone hydrochloride
Generic Name hydromorphone hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

hydromorphone hydrochloride 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6151
Product ID 0641-6151_4c244852-0374-445f-8419-72e8ec359faa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202159
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2018-07-01

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416151
Hyphenated Format 0641-6151

Supplemental Identifiers

RxCUI
1724276
UNII
L960UP2KRW

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydromorphone hydrochloride (source: ndc)
Generic Name hydromorphone hydrochloride (source: ndc)
Application Number ANDA202159 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6151-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6151-01)
source: ndc

Packages (1)

0641-6151-25 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6151-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6151-01)

Ingredients (1)

hydromorphone hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Hydromorphone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "4c244852-0374-445f-8419-72e8ec359faa", "openfda": {"unii": ["L960UP2KRW"], "rxcui": ["1724276"], "spl_set_id": ["67e79859-4efc-4ea7-8211-cadf746bc864"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6151-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6151-01)", "package_ndc": "0641-6151-25", "marketing_start_date": "20180701"}], "brand_name": "Hydromorphone Hydrochloride", "product_id": "0641-6151_4c244852-0374-445f-8419-72e8ec359faa", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6151", "dea_schedule": "CII", "generic_name": "Hydromorphone Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromorphone Hydrochloride", "active_ingredients": [{"name": "HYDROMORPHONE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA202159", "marketing_category": "ANDA", "marketing_start_date": "20180701", "listing_expiration_date": "20261231"}